| Primary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 | Non-adjuvanted Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator GSK Biologicals' candidate recombinant M. tuberculosis vaccine, non-adjuvanted, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG004 | Control Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the adjuvant system alone, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
| | Units | Counts |
|---|
| Participants | - OG00040
- OG00140
- OG00210
- OG003
|
| | Title | Denominators | Categories |
|---|
| Any Pain, Dose 1 | | | Title | Measurements |
|---|
| - OG00038
- OG00140
- OG0029
- OG003
|
|
| |
| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 7-day (Days 0-6) follow-up period after each vaccine dose and across doses | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group |
|
| Primary | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 30-day (Days 0-29) follow-up period after each vaccine dose | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
|
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the Active Vaccination Phase (from Day 0 up to Month 2) | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
|
| Primary | Number of Subjects With SAEs | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | From Month 2 up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
|
| Primary | Number of Subjects With SAEs | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 2 continued only for the M72/AS01B Group and M72/AS02A Group. | The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 2 Safety Follow-Up (M72/AS01B and M72/AS02A groups). | Posted | | Count of Participants | | Participants | | From Month 12 up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
| |
| Primary | Number of Subjects With SAEs | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Follow-up during Year 3 continued only for the M72/AS01B Group and M72/AS02A Group. | The analysis was performed on the Total Vaccinated cohort (all subjects with at least one vaccine administration documented and with the symptom sheet filled in) and focused on the subjects included in the Year 3 Safety Follow-Up (M72/AS01B and M72/AS02A groups). | Posted | | Count of Participants | | Participants | | From Month 24 up to Month 36 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
| |
| Primary | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | |
|
| Primary | Number of Subjects With Normal and Abnormal Haematological and Biochemical Levels | Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 7 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | |
|
| Primary | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | |
|
| Primary | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 37 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | |
|
| Primary | Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels | Among haematological and biochemical parameters assessed were Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Basophils, Creatinine, Eosinophils, Haemoglobin, Haematocrite, Lymphocytes, Monocytes, Neutrophils, Platelets, Red blood cells (RBC), White blood cells (WBC). Inside = within laboratory reference range; Above = above laboratory reference range; Below = below laboratory reference range. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | At Day 60 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | |
|
| Primary | Levels of C-reactive Protein | The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of C-reactive Protein | The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 1 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of C-reactive Protein | The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 7 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of C-reactive Protein | The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of C-reactive Protein | The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 31 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of C-reactive Protein | The levels of C-reactive protein are expressed in milligram per deciliter (mg/dL). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | mg/dL | | At Day 37 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of Immunoglobulin E | The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | 1000 U/L | | At Day 0 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of Immunoglobulin E | The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | 1000 U/L | | At Day 1 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of Immunoglobulin E | The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | 1000 U/L | | At Day 7 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of Immunoglobulin E | The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | 1000 U/L | | At Day 30 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of Immunoglobulin E | The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | 1000 U/L | | At Day 31 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Primary | Levels of Immunoglobulin E | The levels of Immunoglobulin E are expressed in 1000 units per liter (1000 U/L). | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | 1000 U/L | | At Day 37 | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG003 |
|
| Secondary | Antibody Concentrations Against Mycobacterium Tuberculosis (M. Tuberculosis) Fusion Proteins M72 and Mtb72F | Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The reference seropositivity cut-off values for anti-M72 and anti-Mtb72F antibodies were ≥ 2.8 EU/mL and ≥ 1.0 EU/mL, respectively. | The analysis was performed on the According to protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | | | | ID | Title | Description |
|---|
| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group |
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| Secondary | Antibody Concentrations Against M. Tuberculosis Fusion Protein M72 | Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EU/mL). The reference seropositivity cut-off value for anti-M72 antibodies was ≥ 2.8 EU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group). | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | At Year 2 (Month 24) and Year 3 (Month 36) | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
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| Secondary | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/CD8+) T-cells Expressing at Least Two Different Cytokines | Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). Note: No vaccine induced responses were observed for CD8+ T-cells, so no results are presented throughout the record. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Median | Inter-Quartile Range | CD4+ T-cells/million cells | | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
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| Secondary | Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least Two Different Cytokines | Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs). | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group). | Posted | | Median | Inter-Quartile Range | CD4+ T-cells/million cells | | At Year 2 (Month 24) and Year 3 (Month 36) | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
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| Secondary | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | Expressed cytokine combinations for CD4+ T-cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Median | Inter-Quartile Range | CD4+ T-cells/million cells | | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | |
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| Secondary | Frequency of M72 Specific CD4+ T-cells Expressing at Least One Cytokine and Another Signal Molecule | Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group). | Posted | | Median | Inter-Quartile Range | CD4+ T-cells/million cells | | At Year 2 (Month 24) and Year 3 (Month 36) | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
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| Secondary | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Count of Participants | | Participants | | At Day 0, prior to Dose 2 (Month 1), 1 month post-Dose 2 (Month 2) and Year 1 (Month 12) | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | |
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| Secondary | Number of Subjects With Response to M72-specific CD4+ T-cells Secreting at Least Two Different Cytokines/Activation Markers | The cut-off value used for analysis of the frequency of cells expressing cytokines/immune markers was the 313 CD4+ T-cells per million CD4+ T-cells, i.e. the 95th percentile of the pre-vaccination level of cells expressing cytokines/immune markers. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the Month 24 and Month 36 time points (M72/AS01B group and M72/AS02A group). | Posted | | Count of Participants | | Participants | | At Year 2 (Month 24) and Year 3 (Month 36) | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
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| Secondary | Concentrations of IFN-γ Produced in Serum Samples | Concentrations are presented as geometric mean concentrations (GMCs), expressed in picogram per milliliter (pg/mL). The reference seropositivity cut-off value was equal to or above (≥) 1 pg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | pg/mL | | Prior to (Day 0 and Day 30) and one day (Day 1 and Day 31) after each vaccination | | | | ID | Title | Description |
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| OG000 | M72/AS01B Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS01B vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG001 | M72/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of M72/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. | | OG002 | Mtb72F/AS02A Group | Healthy male or female subjects, between and including 18 to 50 years of age, who received 2 doses of the comparator Mtb72F/AS02A vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 0 and Month 1. |
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